Titration/compliance pack with increasing doses

ABSTRACT

A titration package and method for enabling compliance with a regime of changing dosage of medication over a period of time includes a backing having an array of receivers with the array including a plurality of columns and a plurality of rows. A plurality of sets of tablets are provided with each tablet in a set having a common dose of medication and a different dose than a tablet of a different set. Each set of tablets is disposed in receivers of one having an adjacent row and an adjacent column. Indicia is provided and disposed adjacent to the columns and rows for displaying common days and successive weeks.

The present invention is generally directed to a titration package forenabling compliance with a regimen of changing dosage of medication overa period of time and is more particularly directed to a dosage pack fordosing of oral Memantine for the indication of preventing further nervecell loss in glaucoma patients.

Glaucoma is characterized by damaged to the optic nerve which istypically accompanied by a decrease in normal vision field. An earlysign of possible glaucomatous visual field loss is elevated interocularpressure.

In that regard, glaucoma has typically been treated by medically and/orsurgically lowering elevated interocular pressure. Memantine and othercompounds suitable for chronic administration should be administered toavoid adverse events associated with the drug, for example, patientsprescribed Memantine therapy need to be titrated upwards from 5 mg ofMemantine per day to a maintenance dose of either 10 mg or 20 mg perday. Memantine approved for other indications also requires similartitration schedules to avoid drug-related adverse events.

The present invention is directed to a titration package for enablingcompliance with a regimen of changing dosage of medication over a periodof time and further provides for a method of treating a human patient toreduce damage to retinal ganglion cells associated with glaucomautilizing the titration package in accordance with the presentinvention.

SUMMARY OF THE INVENTION

A titration package for enabling compliance with a regimen of changingdosage of medication over a period of time in accordance with thepresent invention generally includes a backing having an array ofreceivers with the array including a plurality of columns and aplurality of rows.

A plurality of sets of tablets are provided in the receivers. Eachtablet in a set has a common dose of medication and a different dosethan a tablet of a different set. Each set of tablets is disposed inreceivers of one of an adjacent row and an adjacent column.

Indicia is provided and disposed adjacent the columns and rows fordisplaying common days and successive weeks. Thus, the package providesfor a titration schedule which prevents adverse events as a result ofmis-dosing. As a result, the package in accordance with the presentinvention provides for a safer and accordingly more beneficial methodfor enabling compliance with the regimen.

More particularly, in one embodiment of the present invention differentsets of tablets are disposed in different rows with each row beingindicated by a successive week and each column being indicated as adifferent day of the week. In this embodiment, the sets of tabletshaving increased doses are disposed in receivers in rows indicated assuccessive weeks. More specifically, the sets of tablets have 5 mg, 10mg, 15 mg and 20 mg doses of Memantine.

In an alternative embodiment, different sets of tablets are disposed indifferent columns, with each column being indicated as a successive weekand each row being indicated as a different day of the week.

In yet another embodiment of the present invention, the titrationpackage for enabling compliance with a regimen of changing doses ofmedication over a period of time includes a backing having an array orreceivers with the array including a plurality of columns and aplurality of rows. In this embodiment, a plurality of sets of tabletsare provided with each set being disposed in receivers of a plurality ofadjacent rows or a plurality of adjacent columns. This plurality may betwo and each tablet in a set has a common dose of medication and adifferent dose than a tablet in a different set.

Preferably, in this embodiment pairs of adjacent rows have differingsets of tablets. This enables the change of dosage over an eight-weekperiod of time from 5 mg to 20 mg doses of Memantine.

Thus, the present invention provides for a method for enablingcompliance with a regimen of changing dosage of medication with themethod comprising the steps of providing a backing having an array ofreceivers, with the array including a plurality of columns and aplurality of rows. The method further includes disposing a plurality ofsets of tablets and the receivers with each tablet in the set having acommon dose of medication and a different dose than a tablet of adifferent set. Each set is disposed in receivers of one of an adjacentrow and an adjacent column. The method finally includes a step ofproviding indicia adjacent the columns and rows indicating common daysand successive weeks.

A concomitant method in accordance with the present invention providesfor a method of treating a human patient to reduce damage to retinalganglion cells associated with glaucoma with the method comprisingproviding a titration package for enabling compliance with a regimen ofchanging dosage of medication over a period of time. The packageincludes the elements hereinabove recited and further the medicationcomprises Memantine.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may be more clearly understood with reference tothe following detailed description in conjunction with the appendeddrawings of which:

FIG. 1 is a representation of a titration package in accordance with thepresent invention for enabling compliance with a regimen of changingdosage of medication over a four-week period of time;

FIG. 2 is a representation of a titration package similar to that shownin FIG. 1 enabling compliance with a regimen of changing dosage ofmedication over a period of eight weeks; and

FIG. 3 is a representation similar to the titration package shown inFIG. 2 showing an alternative arrangement of days and successive weeks,as will be hereinafter described.

DETAILED DESCRIPTION

The titration package and method in accordance to the present inventionis particularly useful for the dosage of oral medication for infirmedand elderly patients and accordingly the manipulation of tablets enabledby the present invention and tracking of compliance with a titrationschedule is a great advantage. In the case of treatment of glaucoma, andthe use of a medicament, such as, for example Memantine, the progressionof blindness also demands a need for the present invention.

With reference to FIG. 1, there is represented a titration package 10for enabling compliance with a regimen of changing dosage of medicationover a period of time, for example four weeks with the package 10including a backing 12 which includes an array 18 of receivers holding aplurality of sets 24, 26, 28, 30 of tablets 34, 36, 38, 40.

The receivers 20 may be conventional, rupturable blisters as, forexample, as set forth in U.S. RE29,705 which is to be incorporatedherewith in its entirety for the purpose of describing the type ofrupturable receivers suitable for use with the present invention.

The backing 12 may be any suitable plastic or paperboard backing and maybe incorporated into protective coverings, not shown, such as, forexample, shown in U.S. Pat. No. 6,047,829. This patent is to also beincorporated herewith in its entirety by this specific reference theretofor showing a backing and dispensing package construction suitable foruse in the present invention.

With continued reference to FIG. 1, the array 18 of receivers 20includes a plurality of columns indicated by the arrows 44 and aplurality of rows indicated by the arrows 46. Indicia 50, 52 is providedand disposed adjacent the columns 44 and rows 46, preferably on thebacking 12 displays common days and successive weeks.

As shown in FIG. 1, different sets are disposed in different rows 46 asindicated by week 1, week 2, week 3, and week 4. The number followingthe indicia “week” indicating successive weeks and the columns 44indicated as Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, andSaturday indicating different days of the week.

With regard to the treatment of glaucoma, the set 24 includes 5 mg ofMemantine, the set 26 includes tablets of 10 mg of Memantine, the set 28includes tablets of 15 mg of Memantine, and the set 30 includes tabletsof 20 mg of Memantine arranged in the rows 46 indicated as week 1, week2, week 3, and week 4. In accordance with the present invention, apatient utilizing the package and method of the present invention istitrated from a 5 mg dose to a 20 mg dose of the Memantine.

In use, a patient beginning the regimen may start on any given day ofthe week, for example, Tuesday and progressively take the tablets byrupturing the receivers 20 along a row until all of the tablets 34 havebeen dispensed. At that time, the patient begins week 2 of the regimenby taking the tablets 36 disposed in the row 46 indicated by theindicia, week 2.

Thus, the arrangement and dosages of the tablets therein enablescompliance with the regimen of changing the dosage of the medicationover the period of time, four weeks as indicated in FIG. 1.

With reference to FIG. 2, there is shown an alternative embodiment, orpackage, 60 in accordance with the present invention for enablingcompliance with a regimen of changing dosage of medication over a periodof 8 weeks. In this embodiment, a backing 62 is provided with an array66 of receivers 68 with the array being arranged in rows indicated bythe indicia, “week 1–8” and columns indicated as “Sun–Sat”.

In this embodiment, different sets 72, 74, 76, 78 of tablets 82 aredisposed in adjacent rows as shown in FIG. 2 or an adjacent columns asshown in the embodiment 100 of FIG. 3. Character references have beenomitted from FIG. 3 to reduce redundancy in description. It should beclear that the embodiment of 60 and 100 are identical except for thearrangement of columns and rows.

In a method of treating a human patient in accordance with the presentinvention to reduce damage to retinal ganglion cells associated withglaucoma, the titration packages 60, 100 enable compliance with aregimen of changing dosage of medication over a period of time ashereinabove described in connection with the package 10 shown in FIG. 1.

The patient beginning on any of the week completes the removal and useof tablets in a corresponding week in adjacent rows or column beforeproceeding to the next pair of adjacent rows or columns in a manner asdescribed hereinabove in connection with the embodiment 10 shown in FIG.1.

Although there has been hereinabove described a specifictitration/compliance pack in accordance with the present invention forthe purpose of illustrating the manner in which the invention may beused to advantage, it should be appreciated that the invention is notlimited thereto. That is, the present invention may suitably comprise,consist of, or consist essentially of the recited elements. Further, theinvention illustratively disclosed herein suitably may be practiced inthe absence of any element which is not specifically disclose herein.Accordingly, any and all modifications, variations or equivalentarrangements which may occur to those skilled in the art, should beconsidered to be within the scope of the present invention as defined inthe appended claims.

1. A titration package for enabling compliance with a regimen ofchanging dosage of medication over a period of time, the packagecomprising: a backing having an array of receivers, said array includinga plurality of columns and a plurality of rows; a plurality of sets oftablets, each tablet in a set having a common dose of the medication anda different dose than a tablet of a different set, each set beingdisposed in receivers of one of an adjacent row and an adjacent column;different sets of tablets are disposed in different rows, each row beingindicated as a successive week, each column being indicated as adifferent day of the week, sets of tablets having increased doses aredisposed in receivers of rows indicated as successive weeks; and indiciadisposed adjacent the columns and rows for displaying common days andsuccessive weeks.
 2. The package according to claim 1 wherein the setsof tablets have 5 mg, 10 mg, 15 mg, and 20 mg doses of Memantine.
 3. Atitration package for enabling compliance with a regimen of changingdosage of medication over a period of time, the package comprising: abacking having an array of receivers, said array including a pluralityof columns and a plurality of rows; a plurality of sets of tablets, eachtablet in a set having a common dose of the medication and a differentdose than a tablet of a different set, each set being disposed inreceivers of one column; different sets of tablets are disposed indifferent columns, each column being indicated as a successive week,each row being indicated as a different day of the week, sets of tabletshaving increased doses being disposed in receivers of columns indicatedas successive weeks; and indicia disposed adjacent the columns and rowsfor displaying common days and successive weeks.
 4. The packageaccording to claim 3 wherein the sets of tablets have 5 mg, 10 mg, 15 mgand 20 mg doses of Memantine.